Sterilization/Autoclave Validation Specialist

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG ensures compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Position Overview

The Validation Engineer – Serialization will be responsible for the validation and qualification of serialization and aggregation systems within pharmaceutical manufacturing operations. This role will ensure compliance with current regulatory requirements and corporate quality standards while supporting the implementation, maintenance, and optimization of serialization processes and equipment.

Responsibilities

• Lead validation activities associated with serialization and aggregation systems.
• Develop, execute, and review IQ, OQ, PQ, FAT, and SAT protocols.
• Support implementation and lifecycle management of serialization equipment and software platforms.
• Ensure compliance with FDA, EU FMD, DSCSA, and applicable GMP regulations.
• Perform risk assessments and impact evaluations for serialization processes and systems.
• Review and approve validation documentation, test reports, deviations, and change controls.
• Participate in investigations and root cause analysis related to serialization processes.
• Support integration between packaging equipment, vision systems, Level 2, Level 3, and Level 4 serialization systems.
• Collaborate with Quality, Engineering, Manufacturing, IT, Automation, and Packaging departments.
• Support audit readiness efforts and regulatory inspections.
• Assist in troubleshooting serialization and aggregation equipment issues.
• Monitor validation deliverables and project timelines.
• Prepare technical reports and management presentations.

Key Responsibilities

The Validation Engineer will serve as the subject matter expert (SME) for serialization validation activities and will:

• Coordinate serialization validation projects from initiation through completion.
• Ensure compliance with regulatory and corporate validation standards.
• Review and approve protocol execution and associated documentation.
• Evaluate changes impacting serialization systems and packaging processes.
• Support deviation investigations and CAPA implementation.
• Provide technical guidance to project teams and stakeholders.
• Facilitate communication among Engineering, Quality Assurance, Operations, Packaging, and IT groups.
• Ensure data integrity requirements are adequately addressed throughout system validation activities.

Qualifications / Requirements / Knowledge / Skills

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Computer Systems, Biotechnology, or a related technical field.
• Minimum of 3-5 years of experience in pharmaceutical manufacturing environments.
• Demonstrated experience in serialization and aggregation systems validation.
• Strong knowledge of FDA 21 CFR Part 11, Annex 11, Data Integrity, GMP, DSCSA, and serialization regulations.
• Experience with validation lifecycle methodology, including IQ/OQ/PQ execution.
• Familiarity with packaging equipment, vision inspection systems, printers, scanners, and serialization hardware.
• Experience with serialization platforms such as SAP ATTP, TraceLink, Systech, Antares Vision, Optel, or similar technologies.
• Working knowledge of Change Control, Deviations, CAPA, and Risk Management processes.
• Excellent technical writing and documentation skills.
• Strong analytical, troubleshooting, and problem-solving abilities.
• Ability to manage multiple priorities in a fast-paced project environment.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project).
• Bilingual (English and Spanish) preferred.
• Strong verbal and written communication skills with the ability to work effectively in cross-functional teams.

Preferred Qualifications

• Experience supporting serialization projects within packaging operations.
• Knowledge of GAMP 5 validation principles.
• Experience with MES, ERP, and Track & Trace integrations.
• Previous participation in FDA or regulatory inspections.
• PMP, CQV, or equivalent certification is a plus.